Tests safety of new sonrotoclax dose schedules in blood cancers
Tests safety of new sonrotoclax dosing schedules in adults with leukemia or lymphoma.
Plain-language title generated from the registry record
Registry title: A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
Key facts
- Where
- São Paulo and Vitória, BrazilSee the 2 sites
- Phase
- Phase 1/2
Where in Brazil
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia CelularSão Paulo, BrazilTaking people
- Hospital Santa Rita de Cassia AfeccVitória, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BeOne Medicines
- Trial code
- NCT06697184EU 2024-518829-15-00
- Record updated
- 26 October 2026
- Original description
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.Read full original descriptionShow less
A Phase 1/2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
Inclusion: Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2; Adequate organ function and no very recent transfusion or blood growth factor; Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later; Only for participants with Chronic Lymphocytic Leukemia (CLL):; Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease; At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation; Only for participants with Mantle cell lymphoma (MCL):; Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC); Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation; Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter.
Exclusion: Participants with any major surgical procedure ≤ 28 days before first dose of study treatment; Prior systemic treatment for the CLL; Prior exposure to a BCL-2 inhibitor; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply; Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; Positive HIV serology (HIVAb) status unless certain conditions are met; Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment; Participants unable to comply with the requirements of the protocol.